An Observational Study of Faricimab Treatment for Diabetic Macular Edema, Age-related Macular Degeneration, and Retinal Vein Occlusion

An Observational Study on the Efficacy and Safety of Faricimab for Diabetic Macular Edema, Age-related Macular Degeneration, and Retinal Vein Occlusion - FARICIMAB-RO (Observational)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057639

Enrollment

500

Registered

2025-04-17

Start date

2025-04-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Age-related Macular Degeneration, and Macular Edema Secondary to Retinal Vein Occlusion

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria: Diagnosed with diabetic macular edema (DME), age-related macular degeneration (AMD), or retinal vein occlusion (RVO) Treated with intravitreal faricimab Aged 18 years or older at the start of treatment No restriction on gender

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria: Presence of other active ocular diseases (e.g., retinal detachment, uveitis) Underwent other treatments such as laser therapy or surgery during the study period Incomplete clinical records that preclude analysis of key endpoints Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Change in Central Subfield Thickness (CST) from baseline to 24 months after the initiation of treatment	—

Secondary

Measure	Time frame
Change in best-corrected visual acuity (BCVA, logMAR) Resolution rate of intraretinal fluid (IRF) and subretinal fluid (SRF), and time to resolution Recurrence rate and time to recurrence of retinal fluid Final injection interval of intravitreal faricimab Total number of intravitreal faricimab injections Changes in OCT biomarkers before and after treatment, including SRF, IRF, chronic cysts, HRF, DRILs, VMA/VMT, ERM, ELM disruption, EZ disruption, serous PED, SRHM, GA, and fibrotic scar Associations between baseline biomarkers and treatment outcomes (CST change, BCVA change, recurrence) Incidence of ocular and systemic adverse events	—

Measure

Time frame

Change in best-corrected visual acuity (BCVA, logMAR) Resolution rate of intraretinal fluid (IRF) and subretinal fluid (SRF), and time to resolution Recurrence rate and time to recurrence of retinal fluid Final injection interval of intravitreal faricimab Total number of intravitreal faricimab injections Changes in OCT biomarkers before and after treatment, including SRF, IRF, chronic cysts, HRF, DRILs, VMA/VMT, ERM, ELM disruption, EZ disruption, serous PED, SRHM, GA, and fibrotic scar Associations between baseline biomarkers and treatment outcomes (CST change, BCVA change, recurrence) Incidence of ocular and systemic adverse events

—

Countries

Japan

Contacts

Public ContactYuki Mizuki

Yokohama City University Hospital Department of Ophthalmology

mizuki.yuk.xj@yokohama-cu.ac.jp0457872683

Outcome results